Bumetanide 0.5 MG Oral Tablet

INDICATIONS AND USAGE Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

amneal pharmaceuticals ny llc

FDA Reported Adverse Reactions
`[1] nausea` `[2] diarrhoea` `[3] fatigue` `[4] drug ineffective` `[5] vomiting` `[6] dyspnoea` `[7] off label use` `[8] pain` `[9] acute kidney injury` `[10] headache`

4 years ago

ROUND WHITE A 16

HOW SUPPLIED

BUMEtanIDE Tablets, USP for oral administration are available as:

BUMEtanIDE Tablets USP, 0.5 mg are supplied as white to off white, round biconvex, bisected and debossed “A” above and “16” below the bisect on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 69238-1489-1 Bottles of 500: NDC 69238-1489-5

BUMEtanIDE Tablets USP, 1 mg are supplied as white to off white, round biconvex bisected and debossed “AC” above and “41” below the bisect on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 69238-1490-1 Bottles of 500: NDC 69238-1490-5

BUMEtanIDE Tablets USP, 2 mg are supplied as white to off white, round, biconvex, bisected and debossed “AC” above and “42” below the bisect on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 69238-1491-1 Bottles of 500: NDC 69238-1491-5 Storage: Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child- resistant closure, as required. Do not take improper broken tablets, if found in the container. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 11-2019-03

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